desmopressin acetate
- Product NDC
- 62756-529
- 11-digit product format
- 627560529
- Labeler code
- 62756
- Product ID
- 62756-529_129770b0-b59a-4ee3-bc07-2168544c1424
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desmopressin acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091280
- Marketing category
- ANDA
- Marketing start
- 2014-02-20
- Substance
- DESMOPRESSIN ACETATE
- Active strength
- 4 ug/mL
- Pharmacologic classes
- Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- desmopressin acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESMOPRESSIN ACETATE | 4 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XB13HYU18U |
| Rxcui | 849501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-529-40 | Desmopressin Acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
| 62756-529-40 | Desmopressin Acetate | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 6 |
| 62756-529-26 | desmopressin acetate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 62756-529-26 | desmopressin acetate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DESMOPRESSIN ACETATE | ACTIVE INGREDIENT | XB13HYU18U | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| DESMOPRESSIN | ACTIVE MOIETY | ENR1LLB0FP | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| CHLOROBUTANOL HEMIHYDRATE | INACTIVE INGREDIENT | 3X4P6271OX | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 3 | |
| DESMOPRESSIN ACETATE | ACTIVE INGREDIENT | XB13HYU18U | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| DESMOPRESSIN | ACTIVE MOIETY | ENR1LLB0FP | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| CHLOROBUTANOL HEMIHYDRATE | INACTIVE INGREDIENT | 3X4P6271OX | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-529 | DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE ) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220827_9fd48eec-aa24-4888-b99f-d409ada958a7.zip |
| 62756-529 | DESMOPRESSIN ACETATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20200124_2dc2cec8-6953-4a33-9356-11534fba1fb8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62756-529-26 | 62756052926 | 1 VIAL, MULTI-DOSE in 1 CARTON (62756-529-26) / 10 mL in 1 VIAL, MULTI-DOSE | | 2014-02-20 | 0000-00-00 | No | No | Current |
| 62756-529-40 | 62756052940 | 1 VIAL in 1 CARTON (62756-529-40) / 10 mL in 1 VIAL | 1 vial | 2013-01-30 | 0000-00-00 | No | No | Current |